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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: MAV FDA class 2

    Syringe, Balloon Inflation

    Cardiovascular

    View full classification →

    The balloon inflation syringe is a cardiovascular device used to inflate and deflate balloon catheters during interventional procedures such as balloon angioplasty or valvuloplasty, providing controlled pressure delivery. It is classified as FDA Class II under 21 CFR 870.1650 within the Cardiovascular specialty, requiring 510(k) premarket clearance. The product code is MAV and the device is not implanted. Full GMP quality system requirements apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
    Inflation Device
    Fluent inflation device
    Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
    basixTOUCH40 Inflation Syringe
    Fluent Inflation Device
    MASTRO PLUS BALLOON IN-DEFLATION DEVICE
    Presto Inflation Device
    SUMMED INFLATION DEVICE KIT
    ENCORE 26 ADVANTAGE KIT
    BASIXTOUCH
    BASIXCONPAK ANALOG INFLATION SYRINGE
    OXTI INFLATION DEVICE
    ENCORE 26 ADVANTAGE KIT
    ENCORE 26 ADVANTAGE KIT
    ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
    SEDAT FLAMINGO
    QL LOCKING SYRINGE
    DOLPHIN INFLATION DEVICE
    VICEROY INFLATION DEVICE
    VANGUARD REPROCESSED INFLATION DEVICES
    INTELLISYSTEM II COLOR MONITOR
    INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
    MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
    INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)
    USCI IDEAL PTCA KIT
    BREEZE DIGITAL INFLATION DEVICE
    SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
    OSCILFLATOR
    MONARCH AP(TM)
    MEDTRONIC EVEREST INFLATION DEVICE
    MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
    IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
    ANGEION IGITAL ANGEFLATOR
    10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
    ACS ANGIOTRAK(TM) SYSTEM
    MONARCH(TM) INFLATION SYRINGE
    CORDIS INFLATOR DEVICE
    MEDFLATOR INFLATION SYSTEM
    ANGIOPLASTY INFLATOR
    BIPOLAR FORCEPS
    CONDOR ANALOG INFLATION SYRINGE
    LP-60 LOW PRESSURE INFLATION DEVICE
    CONDOR DIGITAL INFLATION SYRINGE
    MORSE BALLOON INFLATION DEVICE
    MAGNUM-20 (TM) INFLATION DEVICE
    DISPOSABLE INFLATION GAUGE
    INFLATION/DEFLATION DEVICE
    SCIMED ENCORE INFLATION DEVICE, MODEL SM2500
    ACS INDEFLATOR XX

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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